No

GUDID 06970890320288

Shenzhen As-Tec Technology Co.,Ltd.

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 06970890320288
• NIH Device Record Key: 4893e0f4-5b57-41cb-88ed-a2b02bf23955
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: No
• Version Model Number: AS8011
• Company DUNS: 421355284
• Company Name: Shenzhen As-Tec Technology Co.,Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06970890320288 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143268

FDA Product Code

• NUH: Stimulator, Nerve, Transcutaneous, Over-The-Counter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-17
• Device Publish Date: 2020-09-09

On-Brand Devices [No ]

• 06970890320288: AS8011
• 06970890320622: AS816